Maintaining a Culture of Compliance - Pharmaceutical Executive


Maintaining a Culture of Compliance

Pharmaceutical Executive


To ensure that a culture of compliance is sustained, it must be a core component of every company's training curriculum, sales processes, and incentive programs. With the evolution of more subtle off-label violations, now may be the right time to enhance and advance the training curriculum that you currently have in place.

Organizations and training departments need to keep up to date on the changes in the regulatory landscape and government trends as they pertain to off-label violations. The violative behaviors of today have moved from blatant off-label promotion to more subtle behaviors. Companies must ensure that their sales forces understand what the subtle violative behaviors look like, as it is these behaviors that put managers, representatives, and companies at risk.

Organizations also need to evaluate the sales processes and incentive programs that surround promotion. Sales processes should support compliant behavior and help integrate compliance into daily activities. Incentive programs should encourage and reward compliant sales success.


Is there a legacy culture with a "no excuses mentality?" Are the qualifiers for promotions and/or leadership awards overtly dominated by performance? The true measure of a leader is one who does the right thing at all times, not just when their performance is high.

Quota goals need to be aligned with the on-label sales potential of the product. In the past, conflicts arose because, in some scenarios, sales goals were higher than on-label potential. Quota teams may have had a broad view of sales potential because they simply looked at competitors' overall potential versus doing one more divedown to match up indications.

As a commercial leader the pressure to make your numbers cannot outweigh the pressure to do what's right. You have to ensure that your leadership is rewarding the right behavior and sending the right message. Just because something is considered right by the culture of an organization, it may not be so by the DoJ.


The ongoing fines and violations accentuate the need to mind the gap between compliance policies and compliant field conduct. This gap can be caused by a variety of sources, as discussed above. With the reputational damage that the industry is under, and the increasing focus on prosecuting individuals, now is the time to asses these areas and mind the gap to ensure a successful transfer of compliance policies and training to field conduct. This will allow companies to responsibly deliver information on their products and continue to create a better quality of life to the patients that the industry serves.

Mary Holloway is Co-Founder and President of Sales and Marketing at DMH BioPharm Advisors. She can be reached at

Dee Mahoney is Co-Founder and President of Operations at DMH BioPharm Advisors. She can be reached at


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